BSC NIH BRAIN And SPARC Device Information

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EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAIN AND SPARCPage 1 of 9NOTE: All systems and products should be considered as investigational-use only in the contextof the NIH BRAIN or NIH SPARC Initiative.VERCISE DEEP BRAIN STIMULATION SYSTEMDescription: 16-channel rechargeable implantable pulse generator. Each of the 16 current controlledelectrode contacts of the pulse generator can be programmed independently as an anode or a cathodeand assigned -100% to 100% (1% step size) of the total current. This unique feature is designed to allowfor precise control of the stimulation field and provide stability of the field over time. The size is 22 ccincluding the e W idthCycle (On/Off)Stim Ramp ONIndependent Areas ofStim (4 Programs with 4Areas per Program)a)b)Range0.1 – 20 mA2-255 Hz10-450 µs1s – 90 min1 – 10 s16The programmable coverage for each individual contact is limited to 12.7mA. A programming interlock is enforced tolimit the total output current to 0mA or less per coverage area. For example, a maximum current output of 12.7mA onone contact would limit the total summed current output on the remaining contacts to 7.3mA within one coverage area.The rate is limited to 255Hz for a given area.July 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAINPage 2 of 9VERCISE PC DEEP BRAIN STIMULATION SYSTEMDescription: Similar to Vercise DBS rechargeable system in terms of stimulation capabilities but uses aprimary cell battery and has a different form factor (33cc including the header). Includes new externalsand software for support of the Directional 8 contact segmented DBS lead.VERCISE GEVIA DEEP BRAIN STIMULATION SYSTEMDescription: Similar to Vercise PC DBS system in terms of capabilities, externals, and directional leadsupport, but with the following changes: Uses a rechargeable battery.Has a smaller form factor (19.8 cc including the header).Includes an MRI mode designed for MR scans under specific conditions.April 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAIN AND SPARCPage 3 of 9GUIDE DBS SOFTWAREDescription: GUIDE DBS Software (GUIDE DBS) is a simulation system that allows the clinician to planthe programming of a patient with a Boston Scientific Deep Brain Stimulation (DBS) System. GUIDE DBSprovides: A view of the Lead(s) relative to the deep brain structures associated with treatment The tools for simulating neuron response to stimulation A visual model of the stimulation field in the context of an anatomical atlas.Using GUIDE DBS, one can determine a starting point for the monopolar review that may reduceprogramming time.July 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAINPage 4 of 98-CONTACT DEEP BRAIN STIMULATION LEADDescription: The DBS Lead consists of 8 cylindrical contacts. The outer diameter of the DBS Leadand contacts is 1.3 mm and is compatible with existing commercially available DBS implantation tools.The DBS Lead can be implanted and attached to the stimulator for both unilateral stimulation (on eitherthe left or right side) and bilateral stimulation.Specifications:FeatureNumber of contactsContact LengthContact spacing (centerto center)Contact spanDistal contact to tipDiameterOverall LengthOuter Jacket tubing(insulation)Contact MaterialDescription81.5mm2.0mm15.5mm 1.3mm1.3mm30cm, 45cmPolyurethanePlatinum/IridiumApril 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAIN AND SPARCPage 5 of 9DIRECTIONAL 8 CONTACT SEGMENTED DEEP BRAIN STIMULATION LEADDescription: Eight-contact segmented lead with current steering.July 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAINPage 6 of 9PRECISION WAVEWRITER SPINAL CORD STIMULATOR SYSTEMDescription: Latest generation 32-channel rechargeable implantable pulse generator (IPG). Each of the 32current-controlled electrode contacts of the pulse generator can be programmed independently as ananode or a cathode and assigned -100% to 100% (1% step size) of the total current. This unique featureis designed to allow for precise control of the stimulation field and provide stability of the field over time.The IPG size is 21.2 cc including the header. Various features allow unique electrode configuration andtiming stimulation patterns. For example:- Up to 4 areas activated simultaneously with different electrode configurations and independentstimulation parameters.- Up to 16 independent programs- Up to 4 schedules combining up to 12 programs in sequences with resolution from seconds todays per program.- MicroBurst3D: a burst waveform with increased resolution in the 0 to 1 second range, within andbetween packets of stimulation.- Unique fields to selectively activate dorsal column or dorsal horn neural elements.Programmable ParametersParameterAmplitudeRatePulse W idthCycle ONCycle OFFRamp UPProgrammable ContactsIndependent Areas of Stimulation per ProgramAvailable ProgramsAvailable SchedulesAvailable Programmable Tabs per ScheduleProgram or Wait Period Duration within 0min0s-90min1-10s or OFF32 IPG Case (Anode/Cathode/OFF)41641210 secs – 7 daysStimulation frequencies displayed are representative of only a single area being used in stimulation. When more thanone area is used, the frequency of stimulation in an area may vary to accommodate pulses in other areas and may beless than the displayed frequency on the Clinician Programmer.Amplitude x Width 12.7uC for all leads other than the 4x8 Surgical lead; Amplitude X Width 9.1uC for the 4x8 surgicallead.April 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAIN AND SPARCPage 7 of 9PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEMDescription: 32-channel rechargeable implantable pulse generator. Each of the 32 current-controlledelectrode contacts of the pulse generator can be programmed independently as an anode or a cathodeand assigned -100% to 100% (1% step size) of the total current. This unique feature is designed to allowfor precise control of the stimulation field and provide stability of the field over time. The size is 21.2 ccincluding the header.Specifications:ParameterAmplitudeRatePulse W idthCycle ONCycle OFFRamp UpProgrammable s-90min1-10s or OFF32 IPG case (Anode/Cathode / OFF)Independent Areas ofStimulation per Program4Available Programs16a)b)Only one Area is available if the rate is 130ppsAmplitude x Width 12.7uC for all leads other than the 4x8 Surgical lead; Amplitude XWidth 9.1uC for the 4x8 Surgical LeadJuly 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAINPage 8 of 9April 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAIN AND SPARCPage 9 of 9PRECISION NOVI SPINAL CORD STIMULATOR SYSTEMDescription:16 channels of multiple independent current control utilizing a primary cell battery and adifferent form factor (33cc including the header).Specifications:ParameterAmplitudeRatePulse W idthCycle ONCycle OFFRamp UpProgrammable ContactsIndependent Areas ofStimulation per ProgramAvailable min0s-90min1-10s or OFF16 IPG case (Anode/Cathode/Off)416Only one Area is available if the rate is 130ppsAmplitude x Width 12.7uC for all leads other than the 4x8 Surgical lead; Amplitude XWidth 9.1uC for the 4x8 Surgical LeadPRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEMDescription: Similar to Precision NOVI specifications but with additional MRI capabilities.July 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAINPage 10 of 9PERCUTANEOUS SPINAL CORD STIMULATOR LEADSDescription: Various 1x8 contact electrode leads with 3 different electrode spacing configuration and 1x16electrode contacts percutaneous linear lead configuration.Additional information can be found at: s/us/currentrev-en/91078744-07 Rev A Perc Leads DFU Entrada2 WW Whisper en US S.pdfSURGICAL PADDLE SPINAL CORD STIMULATOR LEADSDescription: 4x8 and 2x8 surgical paddle lead configurations are available.Additional information can be found at: s/us/currentrev-en/91078747-08 Rev A Surgical Leads DFU WW Whisper en US S.pdfApril 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAIN AND SPARCPage 11 of 9Accessories such as connectors and adapters for connection to other manufacturers’ leads:M8 Connector: allows connection to selected Medtronic leads to a Boston Scientific pulse am/Manuals/us/current-rev-en/9089342909RevA Precision M8 Adapter DFU en-US S.pdfS8 Connector: allows connection to selected St Jude leads to a Boston Scientific pulse am/Manuals/us/current-rev-en/9089389609 RevA Precision S8 Adapter DFU en-USA S.pdfOMG connector: allows connection to selected Medtronic and St Jude leads to a Boston Scientificexternal trial stimulator during a trial evaluation Manuals/us/current-rev-en/9117177301 RevA Precision Spectra OMG DFU en-US S.pdfAdditional information for Spinal Cord Stimulator products can be found /landing-page/US-english.htmlJuly 2018

EXHIBIT C – BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAIN AND SPARC Page 3 of 9 July 2018 GUIDE DBS SOFTWARE Description: GUIDE DBS Software (GUIDE DBS) is a simulation system that allows the clinician to plan the programming of a patient with a Boston Scientific Deep Brain Stimulation (DBS) System. GUIDE DBS provides:

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